510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914184Substantially Equivalent

P2020-8-0 Beam-Limiting Device

Precise Optics, Bay Shore NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914184 is the FDA 510(k) clearance record for P2020-8-0 BEAM-LIMITING DEVICE, a class II device, cleared for Precise Optics on under FDA product code KPW (Device, Beam Limiting, X-Ray, Diagnostic). FDA records list 13 510(k) clearances for Precise Optics, from to . As of , FDA records show no recalls naming K914184.

Clearance record

Decision date
Received
(70 days to decision)
Product code
KPW Device, Beam Limiting, X-Ray, Diagnostic
Regulation
21 CFR 892.1610
Device class
Class II
Review panel
Radiology
Applicant
Precise Optics 239 S. Fehr Way, Bay Shore NY
510(k) summary
Statement
Third party review
No

Clearances, product code KPW

Trailing 12 months

FDA records hold no clearances under product code KPW in the trailing twelve months.

FDA records show no clearances under product code KPW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260